KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histologicznie lub cytologicznie rak płuc w stadium IV
- •Pacjenci, którzy wcześniej nie otrzymywali żadnego systemowego leczenia za raka płuc
- •Posiadanie próbki guza do badań (ze zbiorów szpitalnych lub świeża biopsja z ostatnich 90 dni)
- •Możliwość ukończenia wszystkich badań przesiewowych w wyznaczonym oknie czasowym
✗ Disqualifies
- •Diagnoza drobnokomórkowego raka płuc
- •Osłabiona odporność lub stosowanie leków hamujących układ odpornościowy
- •Kolejny nowotwór wymagający leczenia w ciągu ostatnich 2 lat
- •Przerzuty do mózgu lub błon mózgowych
- •Autoimmunologiczna choroba płuc w przeszłości wymagająca sterydów
- •Aktywna infekcja wymagająca leczenia
- •Poważne problemy z sercem lub zawał w ostatnich 6 miesięcy
- •Infekcja HIV
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 28, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (46)
Banner MD Anderson Cancer Center ( Site 0001)
Gilbert, United States
City of Hope ( Site 0014)
Duarte, United States
UCSF Medical Center at Mission Bay ( Site 0007)
San Francisco, United States
Georgetown University ( Site 0036)
Washington D.C., United States
University of Kentucky Markey Cancer Center ( Site 0019)
Lexington, United States
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, United States
Massachusetts General Hospital ( Site 0003)
Boston, United States
Dana Farber Cancer Institute ( Site 0002)
Boston, United States
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)
Omaha, United States
Dartmouth Hitchcock Medical Center ( Site 0016)
Lebanon, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)
Hackensack, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0034)
New York, United States
Sanford Fargo Medical Center ( Site 0039)
Fargo, United States
Cleveland Clinic Main ( Site 0006)
Cleveland, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015)
Columbus, United States
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)
Philadelphia, United States
Sanford Cancer Center ( Site 0038)
Sioux Falls, United States
The University of Texas MD Anderson Cancer Center ( Site 0009)
Houston, United States
Petz Aladar Megyei Oktato Korhaz ( Site 0062)
Győr, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)
Szolnok, Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)
Budapest, Hungary
Soroka Medical Center ( Site 0072)
Beersheba, Israel
Rambam Health Care Campus-Oncology ( Site 0076)
Haifa, Israel
Shaare Zedek Medical Center ( Site 0075)
Jerusalem, Israel
Meir Medical Center ( Site 0071)
Kfar Saba, Israel
Rabin Medical Center ( Site 0074)
Petah Tikva, Israel
Chaim Sheba Medical Center ( Site 0070)
Ramat Gan, Israel
Sourasky Medical Center ( Site 0077)
Tel Aviv, Israel
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Italy
IRCCS Ospedale San Raffaele ( Site 0171)
Milan, Italy
Policlinico Gemelli di Roma ( Site 0174)
Roma, Italy
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)
Koszalin, Poland
Seoul National University Bundang Hospital ( Site 0081)
Seongnam-si, South Korea
Severance Hospital ( Site 0080)
Seoul, South Korea
Samsung Medical Center ( Site 0082)
Seoul, South Korea
ICO L Hospitalet ( Site 0090)
L'Hospitalet de Llobregat, Spain
Hospital Universitario Quiron Madrid ( Site 0091)
Madrid, Spain
Changhua Christian Hospital ( Site 0181)
Changhua, Taiwan
Taipei Medical University Hospital ( Site 0180)
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0182)
Taoyuan, Taiwan
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)
Cherkasy, Ukraine
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0460)
Ivano-Frankivsk, Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)
Rivne, Ukraine
Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)
Uzhhorod, Ukraine
Trial contact
Toll Free Number
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/29/2026.
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